Medicines Act 1975

Medicines Act 1975 2020 REVISED EDITION This revised edition incorporates all amendments up to and including 1 December 2021 and comes into operation on 31 December 2021 An Act to make provisions with respect to medicinal products and medical advertisements and matters connected therewith; and to make consequential amendments to the Poisons Act 1938. [24 June 1977: Parts I and II, sections 30, 31, 34, and 35 of Part III, Part V and sections 54 to 75 of Part VII ; 15 November 1977: Part VI ; 16 January 1981: Part IV ; 3 May 1993: Part III except sections 30, 31, 34 and 35 ] PART 1 PRELIMINARY Short title and commencement 1.—(1) This Act is the Medicines Act 1975. (2) Section 76 and the Second Schedule come into operation on a date that the Minister appoints by notification in the Gazette. [S 759/2022] General interpretation 2.—(1) In this Act, unless the context otherwise requires — “administration” means giving or applying to a human being or an animal, whether orally, by injection or by introduction into the body in any other way, or by external application, whether by direct contact with the body or not; and any reference in this Act to administering a substance or article is a reference to administering it either in its existing state or after it has been dissolved or dispersed in, or diluted or mixed with, some other substance used as a vehicle; “analysis” includes micro-biological assay and “analyse” has a corresponding meaning; “analyst” means an analyst appointed by the licensing authority; “animal” includes any bird, fish or reptile; “assemble”, in relation to a medicinal product, means enclosing the product (with or without other medicinal products of the same description) in a container which is labelled before the product is sold or supplied, or, where the product (with or without other medicinal products of the same description) is already enclosed in the container in which it is to be sold or supplied, labelling the container before the product is sold or supplied in it, and “assembly” has a corresponding meaning; “Authority” means the Health Sciences Authority established under the Health Sciences Authority Act 2001; “Chief Executive of the Authority” means the person appointed under section 15 of the Health Sciences Authority Act 2001 to be the Chief Executive of the Authority; “clinical trial” means an investigation or series of investigations consisting of the administration of one or more medicinal products of a particular description by, or under the direction of — (a) a doctor or dentist to one or more of his or her patients; or (b) two or more doctors or dentists, each product being administered by or under the direction of one or other of those doctors or dentists to one or more of his or her patients, where (in any such case) there is evidence that medicinal products of that description have effects which may be beneficial to the patient or patients in question and the administration of the product or products is for the purpose of ascertaining whether, or to what extent the product has, or the products have, those or any other effects, whether beneficial or harmful; “composition”, in relation to a medicinal product, means the ingredients of which it consists and the proportions, and the degrees of strength, quality and purity, in which those ingredients are contained in it respectively; “container”, in relation to a medicinal product, means the bottle, jar, box, packet or other receptacle which contains or is to contain it, not being a capsule, cachet, or other article in which the product is or is to be administered, and where any such receptacle is or is to be contained in another such receptacle, includes the former but does not include the latter receptacle; “contravention” includes failure to comply and “contravene” has a corresponding meaning; “dentist” means a person registered under the Dental Registration Act 1999 whose name appears in the first division of the Register of Dentists; “disease” includes any injury, ailment or adverse condition whether of body or mind; “doctor” means a person registered under the Medical Registration Act 1997; “herbal remedy” means a medicinal product consisting of a substance produced by subjecting a plant or plants to drying, crushing or other process or of a mixture whose ingredients are 2 or more substances so produced, or of a combination of such mixture with water or such other inert substances as the licensing authority may, by notification in the Gazette, specify; “hospital” includes any institution for the reception and treatment of the sick and designated as a hospital by the Minister for the purposes of this Act; “import” means import into Singapore whether by land, sea or air and “export” has a corresponding meaning; “ingredient”, in relation to the manufacture or preparation of a substance, includes anything which is the sole active ingredient of that substance as manufactured or prepared; “labelling”, in relation to a container or package of medicinal products, means affixing to or otherwise displaying on it a notice describing or otherwise relating to the contents, and “label” has a corresponding meaning; “leaflet” includes any written information; “licensing authority” means the appropriate licensing authority as defined in section 4(1); “manufacture”, in relation to a medicinal product, includes any process carried out in the course of making the product, but does not include dissolving or dispersing the product in, or diluting or mixing it with, some other substance used as a vehicle for the purpose of administering it; “medicinal test on animals” means an investigation or series of investigations consisting of any of the following: (a) the administration of a medicinal product of a particular description to one or more animals, where there is evidence that medicinal products of that description have effects which may be beneficial to, or otherwise advantageous in relation to, that animal or those animals, and the product is administered for the purpose of ascertaining whether, or to what extent, it has those or any other effects, whether advantageous or otherwise; (b) the administration of a medicinal product to one or more animals in circumstances where there is no such evidence as is mentioned in paragraph (a), and the product is administered for the purpose of ascertaining whether, or to what extent, it has any effects relevant to a medicinal purpose; (c) the administration of any substance or article, other than a medicinal product, to one or more animals for the purpose of ascertaining whether it has any effects relevant to a medicinal purpose or whether there is evidence that it has effects which may be beneficial to, or otherwise advantageous in relation to, that animal or those animals; “midwife” means a registered midwife within the meaning of the Nurses and Midwives Act 1999; “Minister” means — (a) except as provided in paragraph (b), the Minister for Health; and (b) for the purpose of performing any function under this Act (whether by the making of any regulations or order or otherwise) where the function is performed exclusively in relation to veterinary medicinal products and animals, the Minister for National Development; “nurse” means a registered nurse or enrolled nurse within the meaning of the Nurses and Midwives Act 1999; “package”, in relation to any medicinal product, means any box, packet or other article in which one or more containers of the products are or are to be enclosed, and, where any such box, packet or other article is or is to be itself enclosed in one or more boxes, packets or other articles, includes each of the boxes, packets or articles in question; “pharmacist” means a person who is registered as a pharmacist under the Pharmacists Registration Act 2007 and has in force a valid practising certificate issued under that Act; “plant” includes any part of a plant; “practitioner” means a doctor, dentist or veterinary surgeon; “product licence”, “manufacturer’s licence” and “wholesale dealer’s licence” have the meanings given by sections 5 and 6 and include any such provisional licence; “retail sale”, in relation to a medicinal product, has the meaning given by subsection (2); “sell” includes barter, and also includes offering or attempting to sell, or receiving for sale, or having in possession for sale, or exposing for sale, or sending or delivering for sale, or causing or allowing to be sold, offered or exposed for sale, and “sale” and “sold” have corresponding meanings; “substance” means any natural or artificial substance whether in solid or liquid form or in the form of gas or vapour; “supply” includes having in possession for the purpose of supply; “treatment”, in relation to disease, includes anything done or provided for alleviating the effects of the disease, whether it is done or provided by way of cure or not; “veterinary medicinal products” means medicinal products which are manufactured, sold, supplied, imported or exported for the purpose of being administered to animals, but not for the purpose of being administered to human beings; “veterinary surgeon” means a person who holds a veterinary qualification approved by the Minister and who is licensed to treat, vaccinate or inoculate animals or birds under section 53(1) of the Animals and Birds Act 1965; “wholesale dealing”, in relation to a medicinal product, has the meaning given by subsection (2). [46/99; 4/2001; 22/2007; 48/2007; 4/2021] (2) In this Act any reference to — (a) selling anything by way of wholesale dealing is a reference to selling it to a person as being a person who buys it for the purpose of selling or supplying it in the course of a business carried on by that person except that it does not include any such sale by the person who manufactured it; (b) selling by retail, or to retail sale, is a reference to selling a substance or article to a person as being a person who buys it otherwise than for a purpose specified in paragraph (a); and (c) supplying anything in circumstances corresponding to retail sale is a reference to supplying it, otherwise than by way of sale, to a person as being a person who receives it for a purpose other than that of selling or supplying. Meaning of “medicinal product” and related expressions 3.—(1) Subject to the following provisions of this section, in this Act “medicinal product” means any substance or article (not being an instrument, apparatus or appliance) which is manufactured, sold, supplied, imported or exported for use wholly or mainly in either or both of the following ways: (a) use by being administered to one or more human beings or animals for a medicinal purpose; (b) use as an ingredient in the preparation of a substance or article which is to be administered to one or more human beings or animals for a medicinal purpose. (2) In this Act, “a medicinal purpose” means any one or more of the following purposes: (a) treating or preventing disease; (b) diagnosing disease or ascertaining the existence, degree or extent of a physiological condition; (c) contraception; (d) inducing anaesthesia; (e) otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating, reducing or postponing, or increasing or accelerating, the operation of that function or in any other way. (3) Despite subsection (1), in this Act “medicinal product” does not include any substance or article which is manufactured for use wholly or mainly by being administered to one or more human beings or animals, where it is to be administered to them — (a) in the course of the business of the manufacturer or on behalf of the manufacturer in the course of the business of a laboratory or research establishment carried on by another person; (b) solely by way of a test for ascertaining what effects it has when so administered; and (c) in circumstances where the manufacturer has no knowledge of any evidence that those effects are likely to be beneficial to those human beings, or beneficial to, or otherwise advantageous in relation to, those animals, as the case may be, and which (having been so manufactured) is not sold, supplied or exported for use wholly or mainly in any way not fulfilling all the conditions specified in paragraphs (a), (b) and (c). (4) In this Act, “medicinal product” also does not include — (a) substances used in dental surgery for filling dental cavities; (b) bandages and other surgical dressings, except medicated dressings where the medication has a palliative or curative function which is not limited to sterilising the dressings; and (c) substances and articles of such other description or classes as the Minister may specify by order. (5) Where in accordance with subsections (1) to (4) a substance or article is a medicinal product immediately after it has been manufactured, imported or exported as mentioned in subsection (1), or immediately after the first occasion on which it has been sold or supplied as mentioned in that subsection, then it does not cease to be a medicinal product for the purposes of this Act by reason only that, at any subsequent time, it is sold, supplied, imported or exported for use wholly or mainly in a way other than those specified in subsection (1). (6) For the purposes of this Act, medicinal products are of the same description if — (a) they are manufactured to the same specification; and (b) they are, or are to be, sold, supplied, imported or exported in the same pharmaceutical form, and in this Act “description”, in relation to medicinal products, is to be construed accordingly. (7) For the purposes of this Act a document, advertisement or representation is to be taken to be likely to mislead as to the uses or effects of medicinal products of a particular description if it is likely to mislead as to any of the following matters: (a) any purposes for which medicinal products of that description can with reasonable safety be used; (b) any purposes for which such products cannot be so used; (c) any effects which such products when used, or when used in any particular way referred to in the document, advertisement or representation, produce or are intended to produce.